– FOTIVDA is the First Therapy Approved for Adults with Relapsed or Refractory Advanced RCC Following Two or More Prior Systemic Therapies –

– AVEO ACE Patient Support Program in Place to Assist with Access, Affordability, and Treatment Adherence –

BOSTON–(BUSINESS WIRE)–AVEO Oncology (Nasdaq: AVEO) today announced that FOTIVDA® (tivozanib) is now commercially available in the United States (U.S.) ahead of the previous March 31, 2021 guidance. On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

“We are thrilled to begin bringing FOTIVDA to patients battling relapsed or refractory kidney cancer,” said Michael Bailey, president and chief executive officer of AVEO. “With its differentiated tolerability and efficacy profile, FOTIVDA has the potential to serve as a meaningful, evidence-based treatment option for the population of patients who have previously received two prior lines of systemic therapy.”

“We are keenly focused on ensuring that FOTIVDA is available to as many appropriate patients as possible,” said Mike Ferraresso, chief commercial officer of AVEO. “As part of this effort and our commitment to the RCC community, we have put in place an assistance program, AVEO ACE, which we believe will optimize patient access and help patients navigate their treatment journey. With the early FDA approval, the team has worked hard to make FOTIVDA available to patients as quickly as possible through our distribution partners and we believe we are well positioned for the successful launch of FOTIVDA.”

The AVEO ACE Patient Support program is designed to offer a comprehensive suite of services dedicated to providing access and personalized support to patients and their loved ones throughout the FOTIVDA treatment journey. Regardless of a patient’s insurance or financial circumstances, AVEO ACE is available to connect them to resources they may need, with the goal of making access to FOTIVDA simple and streamlined. The program is committed to helping identify payor-specific prior authorizations and appeals to address patient needs, offering programs for insurance related delays, and connecting patients, regardless of insurance type, to resources that can address common access and reimbursement challenges. For more information, please call AVEO ACE at 1-833-FOTIVDA (1-833-368-4832) Monday-Friday from 8:00 AM to 8:00 PM Eastern Time.

FOTIVDA is available through a limited distribution network comprised of specialty pharmacies (Biologics & Onco360) and specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty.

About FOTIVDA® (tivozanib)

FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models1. FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

About AVEO Pharmaceuticals, Inc.

AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO’s strategy is to focus its resources toward the development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO’s pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO’s earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “design,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO’s planned timing for making FOTIVDA available to patients in the U.S and efforts to ensure it is available to as many patients as possible; the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; the potential of the AVEO ACE Patient Support program to make patient access to FOTIVDA simple and to offer comprehensive services to patients regardless of insurance or financial circumstances; AVEO’s execution of its clinical and regulatory strategy for tivozanib; AVEO’s plans and strategies for current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of FOTIVDA in the United States; the advancement of AVEO’s pipeline, including the advancement of ficlatuzumab in multiple clinical studies; the potential outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab and AV-380 in areas of unmet need and AVEO’s strategy, prospects, plans and objectives for FOTIVDA and its product candidates and for AVEO generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to successfully implement its strategic plans, including its ability to successfully commercialize FOTIVDA and to obtain and maintain market and third party payor acceptance of FOTIVDA; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the commercialization of FOTIVDA; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy, and clinically meaningful benefit of AVEO’s product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; AVEO’s dependence on third-party vendors for the development, manufacture and supply of FOTIVDA and its product candidates; and AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to maintain compliance with regulatory requirements applicable to FOTIVDA and its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; uncertainties related to AVEO’s ability to access future borrowings under the Hercules loan agreement, which turns on the achievement of milestones related to the commercialization of FOTIVDA in the U.S., which milestones may not be achieved; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

References

  1. Pawlowski N et al. AACR 2013. Poster 3971
  2. J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
  3. Decision Resources. RCC landscape and forecast. December 12, 2019.

Contacts

AVEO Public Relations Contact:
David Pitts, Argot Partners
(212) 600-1902
aveo@argotpartners.com

AVEO Investor Relations Contact:
Hans Vitzthum, LifeSci Advisors
(617) 430-7578
hans@lifesciadvisors.com

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Positive Quality Intervention: Enzalutamide (Xtandi) In Castration-Resistant Prostate Cancer or Metastatic Castration-Sensitive Prostate Cancer

Description: The purpose of this PQI is a summary of process for initiating and monitoring enzalutamide therapy in patients with either castration-resistant prostate cancer or metastatic castration-sensitive prostate cancer (mCSPC).1

Background: Enzalutamide is a pure androgen receptor inhibitor approved in August of 2012 for the treatment of castration-resistant prostate cancer. It gained approval for metastatic castration-sensitive prostate cancer in December of 2019.  The efficacy in patients with either castration-sensitive or castration-resistant prostate cancer was demonstrated in 5 major clinical trials: AFFIRM, PREVAIL, TERRAIN, PROSPER, ARCHES (see Supplemental Information section). Enzalutamide therapy in mCSPC is recommended both by National Comprehensive Cancer Network (Category 1)9 and American Urological Association Guidelines (Strong Recommendation; Evidence Level: Grade A)8 however is underutilized among new patients both in oncology and urology settings. Enzalutamide use in mCSPC should be considered as a potential and evidence-based option.

PQI Process: Identify patients of CRPC and mCSPC and evaluate eligibility for second-generation anti-androgens such as enzalutamide. Upon receipt of a new prescription for enzalutamide for prostate cancer:

  • Initial dosing for all indications is 160 mg once daily
    • Available as 40 mg tablets, 40 mg capsules, or 80 mg tablets
    • Swallow capsules or tablets whole
    • Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy
    • Reduce enzalutamide dose accordingly if co-administered with:
      • Strong CYP2C8 inhibitors – 80 mg daily
      • Strong CYP3A4 inducers – 160 mg to 240 mg once daily
    • Monitor LFTs at baseline and periodically throughout duration of therapy
    • Monitor blood pressure at baseline and throughout therapy
    • Dose modifications
      • Grade ≥3 toxicity or intolerable side effects, withhold dosing for 1 week or until symptoms improve to ≤ Grade 2, then resume at the same dose or a reduced dose (120 mg or 80 mg), if warranted
    • Review concomitant anticoagulation medications and adjust accordingly7

Patient Centered Activities:

  • Provide Oral Chemotherapy Education (OCE) Sheet
  • Administration: Can be taken with or without food at the same time once daily
  • Review baseline labs and chronic medications – dose adjustment needed with concomitant CYP3A4 inducers or CYP2C8 inhibitors
  • Storage: Store at room temperature in the original bottle; do not remove desiccant from bottle

References:

  1. Xtandi (enzalutamide) [prescribing information]. New York, NY: Astellas Pharma US, Inc; 2020.
  2. Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4. Erratum in: Lancet Oncol. 2014 Oct;15(11):e475. PMID: 25104109.
  3. Beer TM, Armstrong AJ, Rathkopf D, et al. Enzalutamide in men with chemotherapy-naïve metastatic castration-resistant prostate cancer: extended analysis of the phase 3 PREVAIL study. Eur Urol 2017;71(2):151-4.
  4. Shore ND, Chowdhury S, Villers A, et al. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomized, double-blind, phase 2 study. Lancet Oncol 2016;17(2):153-63.
  5. Hussain M, Fizazi K, Saad F, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med 2018;378(26):2465-74.
  6. Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al: ARCHES: A randomized, phase III study of androgen-deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J Clin Oncol 37:2974-2986, 2019
  7. Shatzel JJ, Daughety MM, Olson SR, et al. Management of Anticoagulation in Patients With Prostate Cancer Receiving Enzalutamide. J Onco Prac 2017;13(11):720-728.
  8. Lowrance WT, Breau RH, Chou R et al: Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART I. J Urol 2021; 205: 14
  9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed 2-15-2021.

Supplemental Information:

Xtandi Support Solutions®: Patient Support program

  • Enroll online at XtandiSupportSolutions.com or by calling 1-855-8XTANDI (1-855-898-2634)
  • Benefits Verification
  • Prior Authorization and Denial Appeals Assistance
  • XTANDI Quick Start+® Program
  • XTANDI Patient Savings Program
  • Astellas Patient Assistance Program
  • Financial Assistance Information for Medicare Patients
AFFIRM2PREVAIL3TERRAIN4PROSPER5ARCHES6
Patient PopulationmCRPCmCRPCmCRPCNonmetastatic CRPCmCSPC
Study DesignEnzalutamide + LHRH therapy (n=800)

vs placebo LHRH therapy (n=399)

Enzalutamide + LHRH therapy (n=872)

vs placebo LHRH therapy (n=845)

Enzalutamide + LHRH therapy (n=184)

Vs. bicalutamide + LHRH therapy (n=191)

Enzalutamide + LHRH therapy (n=933)

vs placebo LHRH therapy (n=468)

Enzalutamide + LHRH therapy (n=574)

vs placebo LHRH therapy

OutcomesMedian time to first skeletal event: Enzalutamide 16.7 months vs placebo 13.3 months

 

Pain progression at week 13: Enzalutamide 28% vs. placebo 39%

Median overall survival: Enzalutamide 35.3 months vs placebo 31.3 months

 

Median radiographic progression-free survival:  Not reached with enzalutamide + LHRH therapy vs 3.7 months with placebo + LHRH therapy

Median radiographic progression-free survival: Enzalutamide group 19.5 months vs bicalutamide group 13.4 months

 

Median progression-free survival: Enzalutamide patients 15.7 months and bicalutamide patients 5.8 months

Median metastasis-free survival: 3 years with enzalutamide therapy vs 14.7 months with placebo

 

First use of subsequent prostate cancer therapy was delayed by: Median of 3 years with enzalutamide + LHRH therapy vs. 17.7 months with placebo + LHRH therapy

 

Risk of radiographic disease progression or death:

61% reduction with enzalutamide + LHRH therapy vs placebo + LHRH therapy

 

Risk of starting a new antineoplastic therapy: 72% reduction with

enzalutamide + LHRH therapy vs placebo + LHRH therapy

*mCRPC-metastatic castration-resistant prostate cancer, LHRH-luteinizing hormone-releasing hormone, CRPC-castration-resistant prostate cancer, mCSPC – metastatic castration-sensitive prostate cancer


Important notice:
National Community Oncology Dispensing Association, Inc. (NCODA), has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.

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SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, and marks the third approved indication for a Kite cell therapy.

Read the full press release HERE

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March 1, 2021

—U.S. Commercial Launch Underway—

WALTHAM — March 1, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. This indication has been granted under accelerated approval based upon the HORIZON trial. PEPAXTO is the first anticancer peptide-drug conjugate approved in multiple myeloma.

Read the full release here

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Written by: Lauren Trisler, PharmD, BCOP – Carle Cancer Center
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Daratumumab injection is an anti-CD38 monoclonal antibody (mAb) FDA approved for use in a range of multiple myeloma patients including first line, transplant ineligible and relapse/refractory.1 The subcutaneous formulation (DARZALEX FASPRO) is not indicated for front-line transplant eligible patients but is indicated for varied multiple myeloma indications (review supplemental information for reference)6. This PQI will provide guidance for optimal administration and management of both daratumumab infusions and subcutaneous formulation.

Continue reading Daratumumab (Darzalex®) for Multiple Myeloma

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